Pilot Study to Evaluate the Self-Management of Gait, Speech, and Dexterity Symptoms in Parkinson's Disease Using a Smartphone Application

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Digital Placebo Application; Device: Parkinson's Application

• Registration Number: NCT05120609
• Lead Sponsor: Beats Medical

Brief Summary

The purpose of this study is to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients' self-management of gait, speech, and dexterity symptoms.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-15
• Last Update Posted: 2021-11-15
• Study Start: 2021-12
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male and female subjects at least 30 years of age or older,
• History of idiopathic Parkinson's Disease (Hoehn and Yahr stage of II-IV),
• Normal joint range of motion in both legs,
• Able to walk independently for 10 feet with or without an assistive device,
• Parkinson's gait and mild to moderate speech impairment,
• No history of vestibular disease,
• No evidence of dementia (MMSE ≥24),
• Clear benefit from Levodopa,
• Agrees to Beats Medical Application Privacy Policy and Terms of Use,
• Access to an iPhone 7 or higher to use the Beats Medical applications.

Exclusion Criteria

• Medical condition for which exercise is contraindicated,
• History or evidence of neurological deficit other than Parkinson's Disease that could interfere, such as previous stroke or muscle disease,
• History or evidence of orthopaedic or muscular problems,
• Subject is currently enrolled in a study to evaluate an investigational drug or device,
• Subject unable or unwilling to provide informed consent,
• Vulnerable populations as deemed inappropriate for the study by site Principal Investigator,
• History of falls in the past 6 months,
• Pregnancy,
• Current or previous use of the Beats Medical Parkinson's application.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digital Placebo	Digital Placebo Application	Subjects will have access to a digital placebo application and continue usual care.
Parkinson's Application	Parkinson's Application	Subjects will complete at-home allied health therapy exercises delivered through a smartphone application. Subjects will use the application daily for 4 weeks, each daily session takes up to 30 minutes to complete.

Primary Outcome Measures

Name	Time	Method
Change in Gait Velocity (m/s)	Baseline, Week 4, Week 8, Week 12	Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic.

Secondary Outcome Measures

Name	Time	Method
Step Length (m)	Baseline, Week 4, Week 8, Week 12	Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.
MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1	Baseline, Week 4, Week 8, Week 12	Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is designed to monitor the burden and extent of Parkinson's disease. The MDS-UPDRS is divided into 4 parts: (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. In each part, all items are rated on a scale from 0-4, with higher scores reflecting greater severity.; The sum of items 2.1 (Speech) and Part III 3.1 (Speech) will be used to calculate a total score to assess speech abilities.
Step Frequency (steps/min)	Baseline, Week 4, Week 8, Week 12	Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.
MDS-UPDRS Part II Total Score	Baseline, Week 4, Week 8, Week 12	For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score is 0-52, with higher scores reflecting greater severity.
MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5	Baseline, Week 4, Week 8, Week 12	The sum of items 2.7 (handwriting), 3.4 (finger tapping), and 3.5 (hand movements) will be used to calculate a total score to assess manual dexterity. All items are rated on a scale from 0-4, with higher scores reflecting greater severity.
Daily steps	Week 1,2,3,4,5,6,7,8	Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.

Trial Locations

Locations (1)

Meridian Clinical Research; 🇺🇸 Norfolk, Virginia, United States